Long Term Results of 450 Percutaneous Closures of PDA in a Single Center

Patent Ductus Arteriosus Clinical Trial

Official title:

Long Term Results of 450 Percutaneous Closures of PDA in a Single Center

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01929733
• Other study ID #: 0192-13
• Status: Completed
• Phase: N/A
• First received: August 14, 2013
• Last updated: August 21, 2013
• Start date: January 1998
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial Summary

Percutaneous closure is one of the methods used to treat, among other congenital heart disorder, Persistent Ductus Arteriosus (PDA) in children and adults. During the years 1998-2013 four hundred and fifty patients were catheterized in the department of pediatric cardiology and congenital heart diseases in Rambam health care campus, using various devices.

In this retrospective research, the investigators analyze data from patients' medical files, to estimate and define the correlation between the patients' demographic and morphologic data to the type and size of chosen closure device.

Aim of study:

To create an algorithm that can be used to choose the proper device for percutaneous closure of the PDA, based on the characteristics of the patient and the PDA type.

Description:

The investigators analyze the demographic characteristics of patients before the procedure (Age, gender, weight, height, co-morbidities etc.), the type and characteristics of PDA and the chosen device, success and failure rates of the procedure, and adverse effects.

The data is taken from patients' medical files - based on medical reports regarding physical examination, blood tests and imaging studies including cineangiograms and echo-doppler studies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All the patients that underwent percutaneous closure of PDA between January 1998 and august 2013 in the department of pediatric cardiology and congenital heart diseases in Rambam health care campus

Exclusion Criteria:

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus

Locations

Country	Name	City	State
Israel	RAMBAM health care center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Early and late Adverse effects	hemolysis, bleeding, infections ect. due to the fact that the research is retrospective and refers to a period of 15 years (1998-2013)and the fact that some patients had a check-up exam from time to time - the investigators have decided to include in this research the last check-up exam as well.	one day, 10 days and a year after PDA closure and then last check-up exam	No
Primary	Success of implantation	due to the fact that the research is retrospective and refers to a period of 15 years (1998-2013)and the fact that some patients had a check-up exam from time to time - the investigators have decided to include in this research the last check-up exam as well.	one day, 10 days and a year after PDA closure and then last check-up exam	No
Secondary	residual shunt	due to the fact that the research is retrospective and refers to a period of 15 years (1998-2013) and the fact that some patients had a check-up exam from time to time - the investigators have decided to include in this research the last check-up exam as well.	one day, 10 days and a year after PDA closure and then last check-up exam	No